Trial Outcomes & Findings for Understanding Quality and Equity in Wheelchairs for Veterans (NCT NCT01236170)

Results Overview

The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).

Recruitment status

COMPLETED

Target enrollment

497 participants

Primary outcome timeframe

Measured at baseline

Results posted on

2019-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Overall Study STARTED	497
Overall Study COMPLETED	482
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Understanding Quality and Equity in Wheelchairs for Veterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=482 Participants Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Age, Customized <=18 years	0 participants n=5 Participants
Age, Customized Between 18 and 65 years	327 participants n=5 Participants
Age, Customized >=65 years	151 participants n=5 Participants
Sex/Gender, Customized Female	19 participants n=5 Participants
Sex/Gender, Customized Male	462 participants n=5 Participants
Region of Enrollment United States	482 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline

Population: Only 468/482 participants were included in this analysis due to 14 participants having missing data.

The investigators will assess QOL with the Veterans RAND 12 Item Health Survey (VR-12) and two additional physical function items designed for patients with SCI. Eight QOL domains are assessed, including physical functioning, vitality, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health, social functioning, and mental health. The VR-12 has been used extensively with Veterans in a variety of health domains and has shown to be reliable and valid in ambulatory care populations (Cronbach's alpha= .83-.85). The additional two items were added because previous research demonstrated that existing measures of physical function in the VR12 are not appropriate to patients with SCI and are not able to reveal differences in physical function among SCI patients. The investigators assessed physical QOL and mental QOL, both scales range from 0 (worst possible outcome) to 100 (best possible outcome).

Outcome measures

Outcome measures
Measure	Group 1 n=468 Participants Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12) Physical Quality of Life Summary Score	44.7 units on a scale Standard Deviation 7.7
Quality of Life Assessed With the Veterans RAND 12 Item Health Survey (VR-12) Mental Quality of Life Summary Score	43.6 units on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: one time use, at baseline

The investigators assessed Satisfaction with Wheelchair Service Delivery using the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item, easily administered and scored measure of client satisfaction with services (e.g., "How would you rate the quality of service you have received?"). For the purpose of this study, the investigators asked patients to focus specifically on satisfaction with service at their SCI or AL wheelchair clinic. The scale is unidimensional, yielding a homogenous estimate of general satisfaction with services. It is scored by summing the individual items and produces a score ranging from 8-32, with higher scores indicating greater satisfaction. The CSQ-8 has been extensively used in a variety of healthcare settings, operates similarly across ethnic groups, and demonstrates excellent psychometric properties (Cronbach's alpha = .83-.93).

Outcome measures

Outcome measures
Measure	Group 1 n=482 Participants Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Satisfaction With Wheelchair Service Delivery	26.6 units on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: one time use, at baseline

We assessed Satisfaction with patients' prescribe wheelchair using the Quebec User Evaluation of Satisfaction with assistive Technology ( (QUEST). We used an 8-item subset of the QUEST to assess patients' satisfaction with their wheelchair. QUEST is the first and only standardized satisfaction assessment tool that was designed specifically for assistive technology devices. Its' development was based on major theoretical models of assistive technology. The QUEST has been widely cited and used in clinical and research settings, and demonstrates strong psychometric properties (Cronbach's alpha = .82). The 8 item subset focuses specifically on patients' satisfaction with different aspects of their wheelchair (e.g., "How satisfied are you with the dimensions (size, height, length, width) of your assistive device?"). Responses range from 1(not satisfied at all) to 5(very satisfied). Cronbach's alpha = .80 for the 8-item wheelchair subset. We chose to eliminate the other four items.

Outcome measures

Outcome measures
Measure	Group 1 n=482 Participants Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Satisfaction With Prescribed Wheelchair	4.1 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Measured at baseline

Population: 452/482 participants were included in this analysis because 30 participants had missing data.

We assessed participation in society with a modified version of the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF). The CHART was designed to provide a simple measure of involvement in life situations ("In a typical week, how many days do you get out of your house and go somewhere?") with sub-scales measuring physical independence, cognitive independence, mobility, occupation, social integration and economic self-sufficiency. The CHART-SF produces scores ranging from 0 (severe handicap) to 100 (no handicap) for each of the sub-scales and a total score ranging from 0-600. The CHART-SF is the most widely used participation measure in rehabilitation research. It has been used in various ethnic groups, and has well-established psychometric properties (test-retest reliability = .93; inter-rater reliability = .83). We dichotomized into "Disabled" and "Not Disabled" where disabled are those with a CHART score \<100, and not disabled are those with a CHART score \>=100

Outcome measures

Outcome measures
Measure	Group 1 n=452 Participants Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
Participation in Society Disabled (<100)	208 participants
Participation in Society Not Disabled (>=100)	244 participants

SECONDARY outcome

Timeframe: over a two week period following baseline

Population: Access to data is no longer available.

Outcome measures

Outcome data not reported

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Larissa Myaskovsky

VA Pittsburgh Healthcare System

Phone: 4123602241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place